International Medsurg Connection, Inc.

CLOSEOUT LETTER International Medsurg Connection, Inc. MARCS-CMS 511426 — October 16, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Omi Bhati Recipient Title President International Medsurg Connection, Inc. 935 N Plum Grove Road Suite F Schaumburg , IL 60173-4770 United States Issuing Office: Center for Devices and Radiological Health 550 W. Jackson Blvd. 15th Floor Chicago , IL 60661 United States Dear Dr. Bhati: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CHI-09-118 dated May 08, 2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Blake Bevill, MS Program Division Director OMDRHO Division 2 - Central CC:  Kane Ouano, Quality Compliance Manager : Dean Sprake Jones, Quality Manager Content current as of: 10/16/2018